"Re-instrumentation vs Flap Surgery"

NCT ID: NCT05460988

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2024-07-11

Brief Summary

There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.

The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated

Conditions

Periodontal Pocket; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non surgical re-instrumentation

The sites showing remaining pockets (PD\>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.

Group Type: EXPERIMENTAL

Non surgical re-instrumentation

Intervention Type: PROCEDURE

The sites showing remaining pockets (PD\>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.

Flap surgery

All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).

Group Type: ACTIVE_COMPARATOR

Flap surgery

Intervention Type: PROCEDURE

All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).

Interventions

Flap surgery

All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).

Intervention Type: PROCEDURE

Non surgical re-instrumentation

The sites showing remaining pockets (PD\>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥18aa
• Patients with periodontal disease
• Less than 20 cigarettes/day
• No systemic antibiotic therapy in the last 3 months
• At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
• Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
• No previous periodontal surgery at the experimental tooth

Exclusion Criteria

• Connective tissue diseases
• Diabetes
• Pregnancy or lactating
• Furcation involvement
• Crowned tooth
• Severe tooth mobility (class III)
• Radiographical horizontal bone resorption exceeding the 50% of the root

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Luigi Barbato

Clinical professor and principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Florence

Florence, Florence, Italy

Countries

Italy

References

Barbato L, Noce D, Di Martino M, Castelluzzo W, Spoleti F, Rupe C, Nieri M, Cairo F. Non-surgical retreatment versus papillary preservation flap surgery for residual pockets: A randomized controlled trial with clinical and patient-reported outcomes. J Clin Periodontol. 2024 Oct;51(10):1277-1288. doi: 10.1111/jcpe.14047. Epub 2024 Jul 16.

Reference Type: DERIVED

PMID: 39011585 (View on PubMed)

Other Identifiers

18876

Identifier Type: -

Identifier Source: org_study_id